American Ginseng Treatment for Multiple Sclerosis Related Fatigue

Phase 2

Completed

Brief Summary: This research project will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment of MS fatigue.

Detailed Description: Fatigue is a major cause of disability in MS and is associated with a reduced quality of life. Treatment options for MS fatigue include central nervous system stimulants and amantadine. These medications are of limited efficacy, are often poorly tolerated, and can be expensive. Ginseng may represent a novel approach to treating MS fatigue. Ginseng has been tested in clinical trials for its ability to improve mental alertness and fatigue. However, there have been no published clinical trials addressing the effects of ginseng in subjects with MS, even though many people with MS use ginseng and report deriving benefit from it.

This double-blinded, placebo controlled crossover pilot study will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs. placebo for the treatment of MS fatigue. Additionally, the project will collect information on the impact of ginseng on cognition, stress, actigraphy, salivary cortisol, differential cytokine response, and quality of life.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Use of ginseng or stimulants in the prior 6 weeks
Acute treatment with glucocorticoids in the prior 6 weeks
BDI >31
Significant MS exacerbation in prior 30 days
Diabetes
Uncontrolled hypertension
Other serious medical disease, pregnancy or breastfeeding
Breast disease
Abnormal bleeding or clotting disorder
Current use of warfarin, albendazole, nifedipine, digoxin, bumetadine, selegiline, isocarboxazid, or phenelzine
Current use of lasix for poorly controlled hypertension or congestive heart failure
Current drug or alcohol abuse; inability to complete the self report forms

Arm && Interventions

Group	Intervention	Description
1	American ginseng extract HT-1001	Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo
1	placebo	Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo
2	American ginseng extract HT-1001	Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention
2	placebo	Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	after 6 weeks of intervention	The Fatigue Severity Scale (FSS)is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The subject is asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.

Secondary Outcome Measures

Name	Time	Method
Modified Fatigue Impact Scale	6 weeks of intervention	21 item scale, score range 0-84, lower scores indicate less fatigue
Realtime Digital Fatigue Score	6 weeks of intervention	fatigue scored on 0-10 scale with higher scores indicating more fatigue